Mylan recalls 81,000 EpiPens outside US after reports of failure

March 22 (Reuters) - Generic drugmaker Mylan NV has recalled about 81,000 EpiPen devices in countries outside the United States, following two reports of the life-saving allergy shot failing to work in emergencies.

In both situations, patients were able to obtain treatment through the use of an alternate EpiPen, Mylan said on Wednesday.

The recall affects devices distributed in Australia, New Zealand, Europe and Japan only, according to the company.

Mylan said it is working with the regulatory authorities, where appropriate, to inform them about the recall.

The U.S. drugmaker, which is the focus of multiple federal investigations, has come under fire for staggering price increases on the emergency shot in the United States.

Mylan has also been heavily criticized for classifying EpiPen as a generic rather than a branded product, which led to much smaller rebates from the company to state Medicaid programs. (Reporting by Natalie Grover in Bengaluru; Editing by Sai Sachin Ravikumar and Shounak Dasgupta)

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FILE PHOTO -- EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016. REUTERS/Jim Bourg/File Photo

EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016. REUTERS/Jim Bourg

Boxes of Mylan NV's EpiPen 2-Pak allergy shots sit on display for a photograph at a pharmacy in Princeton, Illinois, U.S., on Friday, Aug. 26, 2016. In response to intense criticism over the past few days, Mylan NV moved Thursday to expand assistance programs that help patients with high out-of-pocket expenses -- but didn't go as far as cutting the treatment's list price. Health insurers and U.S. lawmakers criticized the effort as an attempt to cover a 400 percent price hike that won't make the drug more affordable. Photographer: Daniel Acker/Bloomberg via Getty Images

Mylan NV's logo is displayed on a box of EpiPen 2-Pak allergy shots at a pharmacy in Princeton, Illinois, U.S., on Friday, Aug. 26, 2016. In response to intense criticism over the past few days, Mylan NV moved Thursday to expand assistance programs that help patients with high out-of-pocket expenses -- but didn't go as far as cutting the treatment's list price. Health insurers and U.S. lawmakers criticized the effort as an attempt to cover a 400 percent price hike that won't make the drug more affordable. Photographer: Daniel Acker/Bloomberg via Getty Images

Mylan NV's EpiPen allergy shots sit on display for a photograph in Princeton, Illinois, U.S., on Friday, Aug. 26, 2016. In response to intense criticism over the past few days, Mylan NV moved Thursday to expand assistance programs that help patients with high out-of-pocket expenses -- but didn't go as far as cutting the treatment's list price. Health insurers and U.S. lawmakers criticized the effort as an attempt to cover a 400 percent price hike that won't make the drug more affordable. Photographer: Daniel Acker/Bloomberg via Getty Images

This August 24, 2016 photo taken in Hudson, Wisconsin shows a youngster holding Epipens, that he uses to counteract allergic reactions.
A five-fold price hike for EpiPen, which allergy sufferers use to counteract life-threatening reactions, has made Mylan the newest drugmaker to come under attack in the United States for profiteering. Mylan Pharmaceuticals, which holds a near-monopoly position on the epinephrine injectors used by millions against severe allergic attacks, was assailed by two powerful US senators for pumping up the price over six years from $100 to more than $500. That has rendered EpiPens unaffordable to many sufferers -- who must replace them each year -- and is costing the government huge sums to stock schools with them and fund insurance programs which pay for them, the lawmakers said Monday.
/ AFP / Lucas TRIEB (Photo credit should read LUCAS TRIEB/AFP/Getty Images)

This August 24, 2016 photo taken in Hudson, Wisconsin shows Epipens, used to counteract allergic reactions.
A five-fold price hike for EpiPen, which allergy sufferers use to counteract life-threatening reactions, has made Mylan the newest drugmaker to come under attack in the United States for profiteering. Mylan Pharmaceuticals, which holds a near-monopoly position on the epinephrine injectors used by millions against severe allergic attacks, was assailed by two powerful US senators for pumping up the price over six years from $100 to more than $500. That has rendered EpiPens unaffordable to many sufferers -- who must replace them each year -- and is costing the government huge sums to stock schools with them and fund insurance programs which pay for them, the lawmakers said Monday.
/ AFP / Lucas TRIEB (Photo credit should read LUCAS TRIEB/AFP/Getty Images)